An applicant for a stay of an injunction pending appeal
“must establish more than a ‘mere possibility’ both of irreparable injury
absent a stay and of success on the merits of the appeal” to prevail. As for irreparable harm, it was undeniable
that the injunction would cause SPD some harm.Monetary cost alone isn’t sufficient to justify a stay.The cost of a recall here, $3.6 million,
wasn’t insignificant, but SPD didn’t explain how it would irreparably harm the
company.SPD also argued that a recall
would cause loss of consumer trust and goodwill.The court found the magnitude of any such
loss to be speculative; SPD had no evidence that health care providers would change
their views on the quality of the product based on a false advertising recall,
or that consumers would view the product as unsafe or believe it was no longer
approved by the FDA. SPD would “certainly
endeavor to communicate to customers that any recall has no bearing on safety.”In any event, damage to consumer goodwill
wouldn’t be from the injunction or recall, but because of SPD’s “intentional
deception of an egregious nature.” These speculative injuries didn’t rise to the
level of irreparable harm.

SPD argued that it was likely to succeed on the merits of an
appeal, because there’s a post-Pom
Wonderful question of first impression in the Second Circuit on whether the
FDA’s pre-approval of advertising for a medical device precludes Lanham Act
false advertising claims, as well as a serious question as to whether C & D
was entitled to a “presumption of consumer confusion as to all of SPD’s
advertising based on ... intentional deception ... tied to only specific pieces
of advertising.”

So far, all courts to have consider Pom Wonderful have applied it equally to medical device labeling;
the case only strengthens the non-preemption conclusion.Nor did the court here rely only on a
presumption of consumer confusion; it also pointed to C&D’s consumer
surveys, so that undercut the seriousness of the second legal question.
Ultimately, SPD didn’t show that the balance of the equities weighed heavily in
favor of granting the stay, especially given its intentionally false
advertising.

As for injury to C&D, SPD argued that its proposed plan
to “place curative sleeves on the packaging ... would eliminate or mitigate any
loss C&D might suffer from any misleading message on existing packaging.”
But without an injunction in force, SPD would be under no obligation to place
sleeves on the packaging and its product would remain on store shelves without
corrective labeling for the duration of the stay. That would prolong C&D’s
harm, especially in light of the bifurcation of the liability and damages
stages of the case, which would delay C&D’s ability to obtain damages.

The public interest was also served by preventing consumer
deception.

As for the content of the injunction, SPD wanted to sleeve
the existing packages with a new package at their retail locations.The essential difference was what happens
between entry of the injunction and the preparation of new packaging—SPD needs
FDA approval to put new packaging on the product, which SPD estimated would
take two weeks, and then 5-6 more weeks to deliver the new packaging to
retailers.With sleeving, current
misleadingly packaged product would remain on the shelves for at least 7-8
weeks, whereas a recall could begin immediately and be completed within 4
weeks.SPD had already completely ceased
shipping the product in its existing packaging; sleeving would allow SPD to
sell out its current inventory, obviating the need for either recall or
sleeving.“Given the intentional nature
of SPD’s false advertising and the interest of avoiding consumer confusion, the
Product should not be allowed to remain on the shelves for weeks before steps
are initiated to correct false advertising. Thus, this Court concludes that
‘sleeving’ is not an appropriate remedy.”

Thus, the court ordered a recall.

SPD also sought a stay to seek FDA approval for its new
packaging. The court acknowledged the necessary delay brought on by FDA
involvement, but “allowing intentionally false and misleading packaging to
remain on store shelves for a longer period of time in order to accommodate
SPD’s FDA approval schedule is not an appropriate solution,” especially since
SPD could’ve begun seeking approval for new packaging as of the court’s July 1
opinion, but didn’t. Nor would the court
grant a temporary stay to seek a stay from the Second Circuit.

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